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•Jiangsu Hengrui Pharmaceuticals Co., Ltd.•April 4, 2025

FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. - April 04, 2025

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Record Details

An FDA inspection of Jiangsu Hengrui Pharmaceuticals Co., Ltd. in Lianyungang, China, revealed a significant quality system deficiency. The firm failed to establish adequate written procedures for annual evaluations and its annual product review was insufficient in trending to decrease visible particulates in sterile injection products released to the United States.

Company
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Inspection Date
April 4, 2025
Product Type
Drugs
Office
Office of Inspections and Investigations
Person
  • Sara H. Gabel
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ID · eb46bf2d-a78b-4bac-87f4-f509775ee966

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